BridgeMD
New treatment option for Migraine
Official title A Comprehensive Digital Care Program for Migraine Management
ClinicalTrials.gov ID: NCT07642414
What this study is testing
- What it's testing
- This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an FDA-cleared neuromodulation wearable device (Enso), personalized exercise therapy, and a dedicated care team, in reducing migraine frequency among adults with episodic or chronic migraine.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- Documented or clinical history of episodic or chronic migraine (with or without aura) for at least 12 months, consistent with ICHD-3 criteria...
- Passes ID-Migraine Screener with a score of 2 or more "yes" answers to the following question: During the last 3 months, did you experience any of...
- Migraine onset occurred at age 50 years or younger
- Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary
You likely can't join if
- Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted...
- Presence of a metal implant in the head or neck (excluding dental work)
- Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period
- Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note...
- History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal...
- History of major migraine complications (e.g., migrainous infarction or aura-triggered seizure)
See the full eligibility criteria
Who can join
- 18 years of age or older
- Documented or clinical history of episodic or chronic migraine (with or without aura) for at least 12 months, consistent with ICHD-3 criteria. Verification of diagnosis must be established using one or more of the...
- Passes ID-Migraine Screener with a score of 2 or more "yes" answers to the following question: During the last 3 months, did you experience any of the following with your migraines? (1) Your migraines limited your...
- Migraine onset occurred at age 50 years or younger
- Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary
- At least 80% eDiary compliance (minimum of 22 out of 28 days) during the prospective baseline run-in period
- Currently on a stable dose of traditional oral migraine preventive medication (e.g., topiramate, beta-blockers, amitriptyline) for at least 90 days prior to the start of the 28-day baseline period, or taking no...
- Currently on a stable dose of CGRP monoclonal antibodies (e.g., Aimovig, Emgality, Ajovy, Vyepti) or OnabotulinumtoxinA (Botox) for at least 180 days (6 months) prior to the start of the 28-day baseline period
- Willingness to maintain current preventive and as-needed (acute) medication regimens (e.g., triptans, NSAIDs, or abortive gepants) and refrain from initiating any brand new pharmacological or clinical treatments (e.g...
- Sufficient physical mobility to engage with the exercise therapy component of the program, with or without reasonable accommodations; participants reporting significant mobility restrictions (e.g., wheelchair use) will...
- Active commercial health insurance coverage (either as the primary policyholder or a covered dependent) through an employer-sponsored health plan, commercial health insurer, or an affiliated benefit partner eligible for...
- US resident
- Has a valid email account
- Personal ownership of a smartphone (iOS 15 or later, or Android 10 or later) with Bluetooth capability, app store access, and compatibility with the eDiary
- Able to understand and provide voluntary informed consent
What rules you out
- Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device
- Presence of a metal implant in the head or neck (excluding dental work)
- Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period
- Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note: Medication Overuse Headache (MOH) is NOT an exclusion criterion
- History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal Investigator and/or Study Physician, would make the exercise therapy...
- History of major migraine complications (e.g., migrainous infarction or aura-triggered seizure)
- Presence of fever, chills, or night sweats lasting five or more days and not improving
- Significant change in headache pattern, including headaches that are becoming much more severe or frequent, represent a new type of pain, wake the participant from sleep, or worsen with positional changes (e.g...
- Recent changes in vision, mental status, sensation, or strength; or new onset of jaw pain or neck stiffness
- Unexplained significant weight loss (past 3 months), or persistent weakness/numbness in the extremities (past 3 months)
- Known history of conditions that may compromise the immune system
- Head trauma within the past 2 weeks or diagnosis of a spinal fracture or shoulder dislocation within the past 3 months
- Any major trauma, fracture, or significant injury (e.g., car accident, sports injury) within the past 3 months
- Any major surgery within the past 3 months
- Inability to stand up from a chair without assistance (unless the participant utilizes a wheelchair and has been cleared via PT review)
- History of falling due to balance, weakness, vision, or other physical limitations within the past 3 months
- Current diagnosis of epilepsy or active malignancy (history of cancer within the last 5 years)
- Presence of a cognitive or neurological disorder (e.g., dementia, Parkinson's disease) that may interfere with study participation
- Currently unmanaged psychiatric disorder (e.g., schizophrenia, substance abuse, or severe major depressive disorder/anxiety) that, in the opinion of the investigator, could prevent compliance with study instructions
- Pregnant, planning to become pregnant during the study, or currently breastfeeding
- Currently institutionalized
- Insufficient proficiency with the English language to take part in study procedures or complete online surveys
- Current or previous enrollment in any Hinge Health Program or participation in prior Hinge Health research studies
- Current ownership or previous use of an Enso device or other prescribed high-frequency electrical stimulation therapy for the treatment of pain
- Participation in an investigational study within 30 days prior to screening
- Planned travel outside of the U.S. within the first month of enrollment
- Current employees or contractors of Hinge Health, Inc. or L\&E Research, and their immediate family members
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.